Experts in FDA Remmediation

John C. Bloom holds a B.S. degree in biology from the Univ of Pittsburgh and doctorates in veterinary medicine and hematology/oncology from the Univ of Pennsylvania. He completed his postdoc training at Jefferson Medical College in hematology/oncology and served on the Faculty of the Univ of Pennsylvania School of Veterinary Medicine as Chief, Clinical Laboratory Medicine, before joining Smith Kline & French Labs as Assoc Dir of Pathology. He later joined Lilly Research Laboratories as Head, Clinical Pathology, in the Toxicology Division, and subsequently moved to the Medical Division,... Read more

John Ziobro is the Principal Consultant at SpectraMedEx, LLC, a medical device consulting firm specializing in strategic business development. To help grow your company, we focus on three key components of successfully launching your medical devices: 1) Quality Systems & Regulatory Compliance 2) Product Development & Project Management and 3) Global Marketing & Distribution. SpectraMedEx's strength comes from over 30 years of hands-on medical device expertise in Executive Management, Quality and Regulatory Affairs, Project Management, Engineering, New Product Development, Sales,... Read more

18 years of successful Regulatory Consulting and operating a Clinical Research Organization. Hundreds of therapeutic and diagnostic products have been brought to market with our help. We have substantial experience with regulators in multiple disciplines and generally good relationships with them. We work with virtually all branches and divisions of the US FDA. In Clinical Research we have ongoing trials at 11 institutions and support numerous others with clients research and clinical teams. Specialties: Regulatory Strategy, Regulatory Submissions, Regulatory approvals, Clinical... Read more

Qualifications Over thirty years experience in the pharmaceutical / medical device industry. Results-oriented individual with a track record of instituting and maintaining high levels of Quality Assurance, and leadership in the pharmaceutical, medical devices and biological industries. Expert in compliance, auditing, investigations, product complaint, validation, SOP development and assessment, PDMA, cGMP, CFR 21 related items, document control, State and Government regulations. 17 years Government Regulations, inspections, SOP Development. Individual has a minimum of 17 years... Read more

Over thirty years experience in product development, predominately in the medical device industry. Have been a director of both R&D and Program Management. Strong expertise in FDA Design Controls, including creating them as well as developing and conducting associated training for them. Supported FDA Warning Letter at two major medical device companies. Have experience in multiple other industries, including aerospace, defense and retail, and at companies of multiple sizes, including General Dynamics, Honeywell, Select Comfort, Boston Scientific, and St. Jude Medical. Specialties:... Read more

Plamena Entcheva-Dimitrov is a regulatory, clinical and quality management consultant, specializing in the areas of combination products, drug delivery catheters, implantable devices and imbedded and standalone software. Plamena is also the founder of an Eastern Europe oriented US-based CRO focused on accelerating medical innovation and commercialization of medical products to the global markets by reducing clinical study time and cost. Her efforts have allowed patient access to novel technologies and have brought innovative products to the market, expanding and solidifying clients'... Read more

- Broad experience in drug and biologics clinical development clinical development in a variety of therapeutic areas - Development of clinical and regulatory strategy - Management of clinical studies in all phases of development - Strategic Project Management and Portfolio Review - Authoring and compiling protocols and NDAs - Communications with regulatory agencies (FDA, EMEA, Ministry of Health- Japan, Health Canada, etc) - Management of large clinical R&D teams - Due diligence for product purchase or inlicensing Specialties Clinical Development Strategy Communications with... Read more